Ankle FracturesNCT06568276
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
A study testing Additional deep deltoid ligament suture in people with Ankle Fractures and Deltoid Ligament; Sprain (Strain) (Ankle), run by Ostfold Hospital Trust at 9 sites in Norway.
Trial summary
Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle)
- What is being tested?
- Additional deep deltoid ligament suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesNorway
- Study dates
- 20 Sep 2024to 1 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
- previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
- open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
- neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
- fixation of tibial fragment or syndesmotic screw or suture button planned prior to surgery
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Norway9 sites, 9 recruiting
- Recruiting
Ålesund Sjukhehus
Ålesund
Jakup Andreas Thomsen, MD, jakup.andreas.thomsen@helse-mr.no
Ingrid Rieve Kristiansen, MD, ingridrieve@gmail.com
- Recruiting
Haukeland University Hospital
Bergen
Aleksander Uchermann, MD, 95978404 ext. +47, aleksander.uchermann@helse-bergen.no
Jostein Skorpa Nilsen, MD, jostein.skorpa.nilsen@helse-bergen.no
- Recruiting
Nordlandssykehuset Bodø
Bodø
Jonas Larsen Hilmo, MD, jonashilmo@gmail.com
- Recruiting
Sykehuset Innlandet Elverum
Elverum
Ove Talsnes, MD, PhD, 90951744, ove.talsnes@sykehuset.innlandet.no
- Recruiting
Sykehuset Innlandet Gjøvik
Gjøvik
Henrik E. W. Pettersen, MD, +4799402322, hewild@sykehuset-innlandet.no
Audun Dybvik Bøhn, MD
- Recruiting
Oestfold Hospital Trust
Grålum, Postbox 300, N-1714
Frede Jon Frihagen, MD, PhD, ffrihagen@gmail.com
Petter Pettersen, MD, pettergh@gmail.com
- Recruiting
Sykehuset Levanger
Levanger
Esten Konstad Haanæs, MD, 99789013, estenkh@gmail.com
Geir Steinstad, MD, geir.steinstad@helse-nordtrondelag.no
- Recruiting
Oslo University Hospital Ullevål/Aker
Oslo
Carl Erik Alm, +4799298431, alm.carl.erik@gmail.com
Mohammad Ballo, MD
- Recruiting
Stavanger University Hospital
Stavanger
Aksel Paulsen, MD PhD, 98047438 ext. +47, aksel.paulsen@sus.no
Kristianne Gjengedal, MD, kristianne.runestad.gjengedal@sus.no
About this study
Official title: The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-reported Functional Outcome and Radiological Stability Measurements
Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.
Read the detailed description
During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically treated ankle fractures nowadays are on average more complex. The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. This repair also compensates for syndesmotic injury to some extent. The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies.
The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.
- Being tested
- Additional deep deltoid ligament suture
- Medical subject headings
- Ankle Fractures, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional deep deltoid ligament sutureProcedure or surgery
The deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | No intervention | Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only |
| Additional deltoid ligament suture | Experimental | Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus and additional deep deltoid ligament suture Receives: Procedure: Additional deep deltoid ligament suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported functional outcome 1 year after injury
Function will be measured in Olerud-Molander Ankle Score (OMAS) (ankle specific) (0 (worst)-100 (best))
Measured: 1 and 2 years after injury, function 5 years after injury will also be collected
Differences in radiological stability parameters with or without ligament suture at group level
Differences in medial clear space (mm) on weightbearing x-rays or Gravity test at group level
Measured: 1 and 2 years after injury, function 5 years after injury will also be collected
Secondary outcomes (6)
General health state reported through a general (generic) Patient-reported outcome measure (PROM)
The generic Euroquol EQ-5D (EQ 5D-5L) reports general health based on 5 items where Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Measured: up to 5 years
Posttraumatic ankle arthritis
Arthritis seen on weightbearing x-rays will be reported according to Kellgren Lawrence Scale (KGLS) (0 no arthritis to 4 severe/end stage arthritis with bone to bone contact and bone wear and osteophytes)
Measured: 1,2 and 5 years
VAS Pain
scale limited by intervals of no pain (0) and worst imaginable pain (100)
Measured: 6 weeks, 3 months, 1, 2 and 5 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
We will use a version of the Mobility bank 2.1. The setup and calculation method is still not clear. We await further progress from the organization developing this PROM. We hope to get a computer adapted testing (CAT) version of this survey ready in a Norwegian version within the start of 1 year follow up in September 2025
Measured: 1, 2 and 5 years
Self-reported Foot and Ankle Score (SEFAS)
Ankle specific PROM based on 12 items, scale 0(worst) - 48 (best possible)
Measured: 3 months, 1, 2 and 5 years
Ankle Fracture Outcome of Rehabilitation Measure
Ankle Specific PROM based on 15 main items where 0 is the worst index score and 100 the best
Measured: 3 months, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start20 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Helse Nord-Trøndelag HF, Helse-Bergen HF, Norwegian Institute of Public Health, Helse Stavanger HF, Trondheim University Hospital, Norwegian University of Science and Technology, Alesund Hospital, Nordlandssykehuset HF
- Responsible party
- Sponsor
- Investigators
- Frede Jon Frihagen, MD, PhD, Study director, Oestfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568276
- Sponsor's protocol ID
- 2024104
- Status last verified
- Aug 2025
- First submitted
- 22 May 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-reported Functional Outcome and Radiological Stability Measurements
- ClinicalTrials.gov ID
- NCT06568276
- Acronym / sponsor ID
- 2024104
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Helse Nord-Trøndelag HF, Helse-Bergen HF, Norwegian Institute of Public Health, Helse Stavanger HF, Trondheim University Hospital, Norwegian University of Science and Technology, Alesund Hospital, Nordlandssykehuset HF
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.
Detailed description
During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically treated ankle fractures nowadays are on average more complex. The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. This repair also compensates for syndesmotic injury to some extent. The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies.
The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | No intervention | –Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only |
| Additional deltoid ligament suture | Experimental | Procedure: Additional deep deltoid ligament sutureUnstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus and additional deep deltoid ligament suture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
- previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
- open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
- neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
- fixation of tibial fragment or syndesmotic screw or suture button planned prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional deep deltoid ligament sutureThe deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus. | Procedure or surgery | Additional deltoid ligament suture |
Primary outcome
Patient-reported functional outcome 1 year after injury
Time frame: 1 and 2 years after injury, function 5 years after injury will also be collected
Function will be measured in Olerud-Molander Ankle Score (OMAS) (ankle specific) (0 (worst)-100 (best))
Differences in radiological stability parameters with or without ligament suture at group level
Time frame: 1 and 2 years after injury, function 5 years after injury will also be collected
Differences in medial clear space (mm) on weightbearing x-rays or Gravity test at group level
6 secondary outcomes
General health state reported through a general (generic) Patient-reported outcome measure (PROM)
Time frame: up to 5 years
Posttraumatic ankle arthritis
Time frame: 1,2 and 5 years
VAS Pain
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 1, 2 and 5 years
Self-reported Foot and Ankle Score (SEFAS)
Time frame: 3 months, 1, 2 and 5 years
Ankle Fracture Outcome of Rehabilitation Measure
Time frame: 3 months, 1, 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frede Jon Frihagen, MD, PhD study director
Oestfold Hospital Trust
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional deep deltoid ligament suture in people with Ankle Fractures and Deltoid Ligament; Sprain (Strain) (Ankle), run by Ostfold Hospital Trust at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esten Konstad Haanæs, MD (+4799789013, estenkh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported functional outcome 1 year after injury (time frame: 1 and 2 years after injury, function 5 years after injury will also be collected). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.